List of Excipients in Branded Drug OMECLAMOX-PAK

OMECLAMOX-PAK Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 9, 2026

OMECLAMOX-PAK is a 10-day co-pack containing omeprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets for Helicobacter pylori eradication. Its commercial value comes from coordinated dosing and adherence support rather than a novel active ingredient or a single co-formulated dosage form. The strongest product opportunities are generic or authorized-generic co-packs, improved adherence packaging, regional antibiotic-resistance positioning, and reformulated acid-protection systems.

The principal commercial limitation is clinical: clarithromycin-containing triple therapy has a restricted role where clarithromycin resistance is high or susceptibility is unknown. The American College of Gastroenterology’s 2024 guideline advises against empiric clarithromycin triple therapy in most such settings.[1]

What is OMECLAMOX-PAK and how is it formulated?

OMECLAMOX-PAK combines three separately manufactured oral products:

Component	Strength	Dosage form	Functional role
Omeprazole	20 mg	Delayed-release capsule	Suppresses gastric acid and supports antibiotic activity
Amoxicillin	500 mg	Capsule	Antibiotic
Clarithromycin	500 mg	Film-coated tablet	Macrolide antibiotic
Treatment duration	10 days	Co-pack	Organizes twice-daily administration

The labeled regimen is one omeprazole capsule, one amoxicillin capsule, and one clarithromycin tablet in the morning and evening for 10 days.[2]

OMECLAMOX-PAK is therefore a packaging and regimen-management system, not a fixed-dose combination tablet. The separate dosage forms permit independent control of excipient systems, release characteristics, manufacturing sites, and regulatory specifications.

Which excipients are strategically important?

The excipient strategy differs by component.

Omeprazole delayed-release capsule

Omeprazole is acid-labile. Its commercial formulation depends on enteric protection that prevents release in the stomach and allows dissolution in the higher-pH environment of the intestine. The formulation typically uses:

• Enteric-coated pellets or granules
• A protective subcoat
• Hypromellose or similar film-forming polymers
• Methacrylic acid copolymer or another pH-dependent enteric polymer
• Talc
• Polyethylene glycol or another coating plasticizer
• Titanium dioxide and capsule-shell colorants
• Sucrose, starch, or other pellet excipients

The critical technical attributes are acid resistance, dissolution at intestinal pH, moisture protection, and stability during storage. A change in enteric polymer grade, coating weight, plasticizer level, or pellet size can alter release performance.

Amoxicillin capsule

Amoxicillin capsules generally use a relatively conventional powder-fill system. Typical inactive ingredients include capsule-shell gelatin, titanium dioxide, colorants, and formulation aids such as magnesium stearate or other lubricants, depending on the manufacturer and product presentation.[3]

The main formulation risks are powder flow, fill-weight uniformity, capsule brittleness, moisture uptake, and compatibility with the packaging system. Amoxicillin is more straightforward to formulate than omeprazole, but its high dose creates material and capsule-size constraints.

Clarithromycin tablet

Clarithromycin tablets commonly use a conventional immediate-release tablet platform with excipients such as:

• Microcrystalline cellulose
• Croscarmellose sodium
• Povidone
• Magnesium stearate
• Film-coating polymers
• Titanium dioxide
• Talc
• Polyethylene glycol
• Iron oxide or other colorants

The formulation priorities are tablet hardness, rapid disintegration, taste and odor control, coating integrity, and stability. Clarithromycin has a strong bitter taste and can produce a persistent aftertaste if the coating is damaged.

What excipient strategy gives OMECLAMOX-PAK its commercial value?

The primary strategy is functional separation. Each active ingredient retains a dosage form suited to its chemistry:

1. Omeprazole uses enteric protection.
2. Amoxicillin uses a high-load capsule.
3. Clarithromycin uses an immediate-release film-coated tablet.

This design reduces the technical risk of combining incompatible release systems in one tablet or capsule. It also lets a sponsor source or manufacture each component independently.

Why is the co-pack more valuable than a simple three-drug prescription?

The pack can reduce:

• Patient confusion over three medicines
• Omission of one antibiotic
• Incorrect dosing intervals
• Early discontinuation
• Pharmacy dispensing errors
• Need for separate prescription fulfillment

The commercial proposition is strongest when adherence is a payer, prescriber, or pharmacy concern. Packaging, dose labeling, and component identification can create more practical value than incremental excipient changes.

What excipient attributes matter most in development?

Attribute	Highest-risk component	Commercial relevance
Acid resistance	Omeprazole	Determines delayed-release performance
Moisture protection	Omeprazole and amoxicillin	Controls shelf life
Taste masking	Clarithromycin	Supports tolerability and adherence
Color differentiation	All components	Reduces administration errors
Capsule and tablet robustness	Amoxicillin and clarithromycin	Limits breakage and complaints
Pack stability	All components	Determines shelf-life claim
Regulatory precedent	All components	Affects ANDA or 505(b)(2) risk

A sponsor should avoid unnecessary excipient novelty in a generic product. Novel excipients can create regulatory and supply-chain risk without producing a strong market advantage.

What formulation patents could protect an OMECLAMOX-PAK successor?

The original co-pack concept is unlikely to support a durable exclusion strategy on its own. The more defensible opportunities are component-specific or packaging-specific.

Formulation patent opportunities

Potential claim categories include:

• Omeprazole pellet architecture
• Specific enteric polymer ratios
• Moisture-barrier subcoats
• Low-temperature coating processes
• Stabilized omeprazole compositions
• Clarithromycin taste-masking layers
• High-load amoxicillin capsule formulations
• Component-specific impurity controls
• Packaged combinations with defined dissolution profiles
• Unit-dose packaging that maintains stability across all components

Patent strength depends on whether the claims require a measurable technical result, such as improved stability, reduced degradation products, or a defined dissolution profile. Broad claims covering "a proton-pump inhibitor, amoxicillin, and clarithromycin in a package" would face substantial validity and obviousness exposure.

Are excipients themselves strong patent assets?

Usually not. Common excipients such as microcrystalline cellulose, magnesium stearate, hypromellose, talc, titanium dioxide, and standard enteric polymers are difficult to protect broadly. The stronger intellectual-property position generally comes from:

• Unusual excipient combinations
• Defined particle-size distributions
• Specific coating sequences
• Quantified stability improvements
• Manufacturing process controls
• Packaging configurations
• Use of a formulation in a defined patient or resistance setting

Trade secrets can protect coating parameters, processing conditions, and supplier specifications when patent disclosure would provide limited commercial benefit.

What is the FDA regulatory status of OMECLAMOX-PAK?

OMECLAMOX-PAK was approved by the FDA as a prescription treatment for H. pylori eradication and duodenal ulcer disease associated with H. pylori infection.[2] Its regulatory architecture reflects a co-pack of approved dosage forms rather than a new molecular entity.

The principal regulatory routes for a successor product are:

Product strategy	Likely pathway	Main regulatory issue
Same three components, strengths, dosage forms, and regimen	ANDA, if a suitable reference exists	Pharmaceutical equivalence and bioequivalence
Modified omeprazole release system	ANDA or 505(b)(2), depending on differences	Demonstration of equivalent release and clinical relevance
New co-pack with different instructions	ANDA or 505(b)(2)	Labeling and adherence claims
New excipient or novel excipient level	ANDA or 505(b)(2)	Safety, compatibility, and precedent
New indication or resistance-guided use	505(b)(2) or supplemental application	Clinical and labeling evidence

The FDA Inactive Ingredient Database is relevant when evaluating excipient precedent, route, dosage form, and maximum potency.[4] A formulation that uses a listed excipient in an established oral dosage form has a more predictable regulatory path than one that introduces a new excipient or novel delivery mechanism.

What should a generic sponsor match?

A conventional generic co-pack should seek to match:

• Active ingredients
• Strengths
• Dosage forms
• Route of administration
• Dosing frequency
• Treatment duration
• Container-closure configuration
• Labeling instructions
• Relevant dissolution and stability attributes

The omeprazole component is the principal technical challenge because bioequivalence depends on delayed-release behavior, not merely active-content uniformity.

What is the Orange Book and patent status of OMECLAMOX-PAK?

The FDA Orange Book identifies approved drug products, therapeutic-equivalence evaluations, and, where applicable, listed patents and exclusivity.[5] OMECLAMOX-PAK’s commercial barriers should be analyzed at the product, component, and packaging levels.

The likely practical conclusion is that the original branded product does not present the same long-term patent barrier as a currently protected novel therapy. The active ingredients are old, and the key commercial issues are reference-product availability, component sourcing, bioequivalence, labeling, and market demand.

A sponsor should distinguish among:

• Patents listed against the kit
• Patents listed against individual component products
• Formulation patents covering omeprazole delayed-release systems
• Method-of-use patents for H. pylori treatment
• Packaging patents
• Regulatory exclusivity independent of patent rights

A patent search should include the product name, each active ingredient, the original NDA holder, component manufacturers, and relevant U.S. classifications. No Paragraph IV strategy should be inferred solely from the existence of an old brand name. The relevant question is whether an active, Orange Book-listed patent creates a filing or launch risk for the proposed product.

When does OMECLAMOX-PAK lose exclusivity?

The key exclusivity dates are not equivalent to a single patent expiration date.

Exclusivity category	Relevance to OMECLAMOX-PAK
New chemical entity exclusivity	Not applicable to omeprazole, amoxicillin, or clarithromycin
Five-year NCE exclusivity	Not applicable
Three-year clinical-investigation exclusivity	Potentially relevant only if supported by qualifying new clinical work
Orphan exclusivity	Not applicable
Patent term	Depends on any listed product or method patents
Pediatric exclusivity	Depends on an FDA grant tied to qualifying studies
Regulatory exclusivity for a co-pack	Generally limited unless tied to qualifying innovation

Because the product contains long-established active ingredients, the principal entry question is patent status rather than NCE exclusivity. Patent expiration must be confirmed against the applicable Orange Book entries and patent records before filing or launch planning.

Which companies are challenging OMECLAMOX-PAK?

The product is more likely to face competition from component manufacturers and alternative H. pylori regimens than from a single direct branded challenger.

Competitive groups

Generic component suppliers

Manufacturers of generic omeprazole, amoxicillin, and clarithromycin can supply the ingredients or finished products needed for a successor co-pack. The commercial bottleneck is assembling a stable, regulatorily acceptable kit rather than discovering a new active ingredient.

Alternative H. pylori products

The main therapeutic competitors include:

• Bismuth quadruple therapy
• Rifabutin-based triple therapy
• Vonoprazan-amoxicillin dual therapy
• Vonoprazan-based triple therapy
• Other susceptibility-guided regimens

The ACG 2024 guideline places greater emphasis on non-clarithromycin empiric regimens when antibiotic susceptibility is unknown or clarithromycin resistance is prevalent.[1]

Pharmacy-dispensed combinations

Clinicians can prescribe the three components separately. This lowers the barrier to substitution but removes the adherence and convenience advantage of the co-pack.

What generic entry risks exist for OMECLAMOX-PAK?

Generic entry risk is high at the active-ingredient level and moderate at the kit level.

Technical entry risks

• Omeprazole dissolution must match the reference product.
• Separate components may have different expiration dates and storage conditions.
• Clarithromycin coating defects can affect tolerability.
• Packaging must prevent mix-ups between morning and evening doses.
• The kit must maintain stability for the full labeled shelf life.
• Component shortages can disrupt the entire product.

Legal entry risks

Potential disputes could involve:

• Listed patents on the reference product
• Formulation patents for omeprazole delayed-release pellets
• Packaging patents
• Method-of-use patents
• Trade-dress or labeling claims
• Supplier intellectual property

Paragraph IV litigation is most plausible if an active patent is listed against the reference product or a required component. The commercial value of a challenge depends on whether the kit can launch before patent expiry and whether the market is large enough to justify litigation.

How strong is the OMECLAMOX-PAK patent estate?

The estate is likely weak as a platform for broad exclusion and stronger as a source of narrow formulation or process rights.

Patent category	Relative strength
Broad three-drug co-pack claims	Low
Omeprazole enteric-coating claims	Moderate, depending on claim scope and expiry
Clarithromycin taste-masking claims	Moderate if supported by performance data
Manufacturing-process claims	Moderate to strong as trade secrets; variable as patents
Packaging and adherence claims	Low to moderate
Resistance-guided method-of-use claims	Potentially relevant, but clinically and legally narrower

A successor sponsor should build a layered portfolio around measurable stability, dissolution, packaging performance, and manufacturing controls. A single broad combination patent would provide limited protection against component-level substitution.

What licensing deals could support a commercial launch?

The most practical licensing model would involve a kit sponsor licensing or sourcing individual components rather than licensing the original brand.

Potential deal structures include:

• Contract manufacturing of omeprazole delayed-release pellets
• Supply agreements for amoxicillin and clarithromycin
• Authorized-generic arrangements
• Regional co-promotion rights
• Packaging and serialization licenses
• Licensing of a proprietary enteric-coating process
• Distribution agreements in markets with established H. pylori demand

Licensing economics depend on whether the partner contributes a differentiated component. A standard generic supply agreement is more likely to create margin pressure than durable competitive advantage. A proprietary stable omeprazole platform or superior adherence pack could justify royalty-bearing rights.

What commercial opportunities remain for OMECLAMOX-PAK?

1. Generic adherence co-pack

A lower-cost co-pack can compete with separate prescriptions by simplifying the regimen. The opportunity is strongest in markets where pharmacies and prescribers value bundled dispensing.

2. Improved packaging architecture

Potential improvements include:

• Calendarized morning and evening doses
• Large component-specific markings
• Tactile differentiation
• Spanish-language or multilingual instructions
• Unit-dose blister packaging
• QR-linked administration instructions
• Packaging that separates doses by treatment day

Packaging improvements can support trade-secret protection and, in some cases, narrow design or utility patent claims.

3. Resistance-aware positioning

A clarithromycin-containing product should not be positioned as a universal empiric therapy. Commercial targeting can focus on:

• Patients with documented clarithromycin susceptibility
• Regions with lower clarithromycin resistance
• Use under local gastroenterology protocols
• Settings where treatment access favors a low-cost co-pack

This approach narrows the addressable market but improves clinical alignment.

4. Regional product adaptation

Geographic opportunities may exist where:

• H. pylori prevalence is high
• Co-pays favor generic products
• Separate dispensing creates adherence problems
• Diagnostic and susceptibility testing infrastructure is limited
• Local regulators accept established excipient systems

The product must account for country-specific labeling, antibiotic stewardship requirements, packaging language, serialization, and allowable excipients.

5. Reformulation around acid protection

A technically improved omeprazole component could provide the strongest product differentiation. Areas include:

• Lower moisture sensitivity
• More reproducible enteric release
• Reduced degradation impurities
• Improved stability in high-humidity markets
• Smaller capsule size
• More robust blister packaging

The commercial value depends on whether the improvement lowers manufacturing cost, increases shelf life, or reduces product complaints.

How does OMECLAMOX-PAK compare with newer H. pylori therapies?

Attribute	OMECLAMOX-PAK	Bismuth quadruple therapy	Vonoprazan-based therapy
Core acid suppression	Omeprazole	PPI	Potassium-competitive acid blocker
Clarithromycin exposure	Yes	No required	May be included in triple therapy
Resistance sensitivity	High for clarithromycin	Lower than clarithromycin triple therapy	Depends on regimen
Packaging complexity	Moderate	High	Moderate
Generic manufacturing	Relatively accessible	Accessible but more complex	More dependent on protected products
Adherence burden	Six dosage units daily in the labeled regimen	Often higher pill burden	Varies by product
Differentiation potential	Packaging and excipients	Packaging and regimen simplification	Molecule, formulation, and patent estate

OMECLAMOX-PAK has a cost and manufacturing advantage over newer protected therapies but a clinical disadvantage where clarithromycin resistance is substantial.

What revenue exposure should investors and licensors assess?

No reliable current revenue estimate should be assigned to OMECLAMOX-PAK without verified sales data. The relevant exposure variables are:

• Whether the brand is actively marketed
• Availability of a current reference product
• Number of generic components already approved
• Regional H. pylori prevalence
• Clarithromycin resistance rates
• Reimbursement for co-packs
• Cost of packaging and serialization
• Probability of component shortages
• Clinical preference for newer regimens

The revenue opportunity is more likely to be niche and regional than comparable with large protected chronic-care products. The addressable market is constrained by guideline changes and antibiotic resistance.

Key Takeaways

• OMECLAMOX-PAK is a 10-day co-pack of omeprazole, amoxicillin, and clarithromycin.
• Its central excipient challenge is omeprazole’s acid-labile chemistry and delayed-release requirement.
• The strongest technical opportunities involve enteric coating, moisture control, clarithromycin taste masking, and adherence packaging.
• Broad patent protection for the three-drug concept is likely weak because the active ingredients and treatment concept are established.
• Generic entry risk is high at the component level and moderate for a compliant, stable co-pack.
• Clarithromycin resistance is the main commercial constraint.
• A successor product should target susceptibility-guided use, lower-cost access, and packaging-enabled adherence rather than broad empiric positioning.
• The most credible licensing opportunities involve specialized omeprazole technology, contract manufacturing, regional distribution, and packaging systems.

FAQs

Can OMECLAMOX-PAK be converted into one fixed-dose tablet?

Technically, a single tablet would require simultaneous management of omeprazole enteric protection, two antibiotic release profiles, dose loading, stability, and chemical compatibility. A co-pack is more practical because it preserves separate dosage forms.

Which excipient is most important for omeprazole stability?

The enteric-coating and protective-subcoat system is most important. Polymer selection, coating weight, plasticizer level, and moisture control directly affect acid resistance and release.

Is clarithromycin resistance a patent issue or a market issue?

It is primarily a clinical and commercial issue. Resistance can restrict prescribing and reduce market demand even when no patent blocks generic entry.

Can a sponsor patent the OMECLAMOX-PAK packaging?

A sponsor may seek claims covering a specific packaging configuration, dose-sequencing system, or stability-enhancing container. Broad claims covering a three-drug package would face greater validity risk.

Would a 505(b)(2) application be preferable to an ANDA?

An ANDA is generally more efficient when the proposed kit matches the reference product in active ingredients, dosage forms, strengths, route, and labeling. A 505(b)(2) pathway becomes more relevant when the sponsor introduces a materially different release system, excipient platform, dosage form, or clinical use.

References

1. American College of Gastroenterology. (2024). ACG clinical guideline: Treatment of Helicobacter pylori infection. The American Journal of Gastroenterology, 119(9), 1730-1753.

2. U.S. Food and Drug Administration. (n.d.). OMECLAMOX-PAK prescribing information. FDA-approved labeling.

3. National Library of Medicine. (n.d.). DailyMed: Amoxicillin, omeprazole delayed-release, and clarithromycin product labeling. DailyMed.

4. U.S. Food and Drug Administration. (n.d.). Inactive Ingredient Database. FDA.

5. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.